Objective

ESBIO aims at developing a coordinated approach for human biomonitoring (HBM) with focus on children in Europe, in line with Action 3 of the EU E&H Action Plan by providing strong scientific support for the pilot project to be launched end 2006. The project proposal aims to overcome specific deficiencies in EU HBM in particular by generating significant added value with:

- An updated and extended inventory of EU HBM activities and data bases, ensuring relevant activities and stakeholders to be integrated in the development of a coordinated approach and creating a platform for exchange;- Proposals - for a coordinated approach and for a pilot study - for possible objectives, target pollutants and appropriate markers, study design and methods for collection, analysis and evaluation of data, protocol for laboratory coordination;- A concept for integration of biomonitoring with environmental and health monitoring and for translation of HBM results into a response system;- Guidelines for ethical practices;- Guidelines for communication and dissemination of results;- Strategies for wider communication to stakeholders;- An assessment of socio-economic consequences and costs of various alternatives, including a concept to improve cost efficiency;- A concept for coordination, evaluation and follow up of a EU pilot project;- A systematic overview and evaluation of the sensitivity and utility of biomarkers in perspective of a EU pilot project;- A strategy for synergism between environmental health research and a pan EU HBM surveillance network.Members of ESBIO actively participated in the elaboration of the EU E&H Strategy and are active in EU institutions playing a major role in HBM research and surveillance focussing on children. ESBIO is geographically well balanced, involves 62% female and 38% male researchers, has complementary competencies (research, surveillance, ethical issues, socio economic consequences, coordination, management, policy consulting...

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Coordinating human biomonitoring data

Human biomonitoring (HBM) refers to the integration of environmental monitoring with human health, evaluating the types and amounts of chemicals to which people are exposed and the amounts that actually get into their bodies. EU-funded researchers made significant progress in developing recommendations and tools to facilitate the coordination of research efforts on a European scale that promises to protect the health of EU citizens through targeted policymaking and regulation.

The effects of chemicals on children is of particular concern, not only from an emotional standpoint but from a biological one: growing and developing bodies that are highly metabolically active and undergoing rapid changes often have more potential to absorb various chemicals and more potential to be harmed by them.
It is of critical importance that countries define acceptable levels of exposure for the chemicals to which children are exposed, in other words to coordinate experimental data with policy and regulation. The ‘Development of a coherent approach to human biomonitoring in Europe’ (ESBIO) project was undertaken to facilitate a coordinated approach to European HBM, particularly as related to children.
The research team created an extended inventory of European HBM activities, past and present, incorporating self-registration and including information relevant to researchers and stakeholders alike. Data includes people and labs involved in certain projects and entities with expertise in specific analytical areas.
In addition, the investigators focused on rules and practices related to ethical conduct, providing recommendations regarding protocols, biobanking issues, special concerns with respect to the participation of children and harmonisation of overall procedures on a European level.
Finally, the team provided an Excel tool for socioeconomic optimisation of future HBM projects providing the total necessary project budget based on user inputs.
In summary, the ESBIO project made significant progress in developing protocols and tools for coordinating HBM research efforts on a European level, in particular as related to children. Better coordination among EU countries has the potential to elucidate important findings that might otherwise be buried without shared data and shared methods, resulting in better health for EU citizens via more effective policies and regulations.

Final Report Summary - ESBIO (Development of a coherent approach to human biomonitoring in Europe)

The project was outlined as coordinated action which aimed to enable networking and coordination of those institutes playing an active role in European biomonitoring research with a focus on the integration of environmental monitoring and health data and those institutes transposing research results into policy programmes. Accordingly, very close and intensive networking and coordination of the involved parties was crucial in order to achieve the overall objectives: (1) development of a coordinated approach for biomonitoring based on existing expertise and experiences available in Member States surveillance programmes and results from research; (2) elaborate how biomonitoring results can be integrated most efficiently with environmental monitoring and registered health data; (3) develop strategies to communicate biomonitoring results to stakeholders (populations affected, regulators, politicians) including the establishment of websites publicly available and with links to national and international activities resulting in full transparency for all stakeholders; (4) elaborate scenarios for the use of biomonitoring results for policy making.

In order to accompany a European human biomonitoring pilot project a communication strategy has to follow four main principles: - There should be no double work between the involved actors. - There should be a close coordination with other EU activities in the field of E&H - The red thread and the core statements have to match in all communication activities. - The campaign should be flexible and adaptable according to different needs.

In order to meet these principles BIPRO has developed a modular concept which provides a tool to establish an effective and efficient communication. Starting point are the five modules target groups, aims, content to be communicated, actors to realise and tools to be used, which are elaborated in terms of their use for a HBM project supporting communication. To establish a communication strategy the individual modules are linked appropriately in a way to follow the causal chain to whom, why, what, how, who? The concept provides a common ground for communication activities within one project even if they differ greatly from each other e.g. due to different needs and expectations. The concept is ready to be used in a future HBM pilot project by the responsible communication unit.

The concept is ready for use and has to be applied according to the framework in which an HBM pilot project will be performed. With the concept it can be ensured that all concerned actors as well as the general public are involved and will be kept informed on the project performance. As HBM and the link between environment and health is a topic of increasing public awareness it is seen as essential to ensure a maximum of transparency. Actors to realise the communication and therefore to use the concept should be experts for communication on an international level together with experts in the field of HBM. A close cooperation with the institutions performing the project has to be guaranteed. Investments involved depend on several factors like the level of involvement of the Commission or the tools to be used (e.g. brochures, videos, etc.). In main costs will incur within the cost category personnel costs.

In order to perform a socio economic optimisation for a future EU HBM pilot project first of all tasks necessary for a HBM pilot project have been identified. Subsequently an Excel tool has been developed in which different parameters are variable to be filled in by the user and which calculates with the inserted figures the total necessary budget for several different study approaches. In order to achieve the optimal approach several contradictions had to overcome, this means to maximise the number of participating Member States, the biomarkers to be measured, the number of samples, the synergies effects and to maximise the scientific progress while keeping costs as low as possible. In addition a coordination concept has been elaborated proposing different work levels, i.e. performance of the pilot study should be done in each country by a national team; the harmonisation, support and evaluation of the study and its results should be done on EU level by multinational teams. In order to take into account the different levels of existing experiences a research-component should be established. The results have been discussed with all Member States and can be used for a future HBM pilot project.

The results offer an excellent basis for the establishment of an EU wider HMB network performing a harmonised pilot project. The results are usable for a unit setting up an EU network on HBM in Europe. To use the results a high rate of coordination and communication skills is necessary. A team of HBM experts, laboratories, national authorities as well as coordination and communication experts should be formed to use the full range of results. Investments involved only incur in case the HBM pilot project will be realised using the results obtained.

Part of the work concentrated on ethical issues related to present and future biomonitoring programs in EU countries by describing rules and practices in a number of countries and by organising a workshop. Special supplementary issue of the web based journal Environmental Health reporting from the workshop on ethical issues and communication within biomonitoring in Copenhagen March 2007 will be issued and a number of reports are available on the ESBIO web site and in open literature. The recommendations are: - A protocol must be developed at an early stage describing rationale, justification of study, calculation of minimum number of study persons needed for sufficient power of study, recruitment of study persons, informed consent and information of ethics committees before initiation of studies. - Biobanking issues needs to be solved prior to study initiation to ensure legal uses of data and samples. - Incentives for participation must be considered to avoid economic pressure for participants and special concerns have to be made regarding children. - Information to study persons about study results must be described and ensure respect of the right not to know. - Harmonised approaches to steps of recruitment, information, consent, data protection, biobanking, dissemination and data / sample transfer between countries and institutions should be considered e.g. in future directives / guidelines for human environmental biomonitoring in Europe (and worldwide).

One other result is an online inventory of European human research and non-research biomonitoring actions, either ongoing or having been carried out in the last ten years. The online structure and the procedure for self registration of activities provide the optimum strategy for maintaining the available information both accurate and up-to-date. Additional functionalities such as user-defined searches of the activities and the message-board are also favoured by the web environment, and move the inventory closer to the concept developed for a platform for exchange of expertise and experience between human biomonitoring (HBM) stakeholders. The inventory holds potential for impacting all research, industry or policy sectors in any way related to HBM, in that it provides information on what is being done in the field, who is carrying out the actions, what methodologies are being applied and which laboratories have analytical experience in the area. Developments planned for the platform, such as discussion forums and webpages dedicated to specific issues within HBM, including the organisation of events, will expand this potential further through greater user involvement and a larger target public, ensuring the platform self-fulfils its potential, as a larger amount of information is registered and its usefulness consequently increases.

The opportunity for the dissemination of human biomonitoring activities conducted by private or public entities or institutes around Europe is of interest to parties wishing to establish a partnership or exchange information on procedures and practices. This already includes the publicising of specialised analytical services offered by laboratories and intends to include in the future the widespread dissemination of periodic events such as conferences or workshops among a targeted audience with a stated interest in the field. Free and practically unrestricted usage is suggested to be complemented by the charging of e.g. commercial laboratories with an 'advertising' fee for the dissemination of biomonitoring analyses conducted, as a means of funding the upkeep of the online inventory.

Deliverables

Publications

Exploitable Results

As a result of ESBIO WP 3 a "Multi-step Approach" was developed that outlines which steps need to be undertaken to translate HBM data into policy action, trying as much as possible to prioritise among different pollutants measured and different Member States.
The Multi-step approach will eventually lead to:
1. Aggregation of individual data based on geographical entities;
2. Determine whether there is a deviation (increase/decrease) at the aggregated level in one or more biomarkers measured;
3. Determine the seriousness of the deviation, based on a variety of expert opinions;
4. Set priorities in order to deal with these deviations;
5. Track the causes of these deviations, retrace pollutant loads to potential local, external sources, and identify the different actors that may contribute to the pollutant body burden;
6. To suggest appropriate risk reduction strategies, taking into account the relevant knowledge, actors and opinions;
7. To communicate with the general public and policy makers in a transparent and objective way, proposing and motivating different policy options.

Conducting a human bio-monitoring study is a challenging. Guidelines for all critical steps might be helpful for the successful implementation of a human bio-monitoring approach. Beside clarification on the study design emphasis must be laid on a harmonised way of collecting, of analysing the samples and on data management.
In this guideline three steps (sampling, analysing and data management) have been clustered. The guideline might be used by institutions or organisations conducting human bio-monitoring studies to develop Standard Operating Procedures (SOPs) for each step described.

Workpackage 4 concentrated on ethical issues related to present and future bio-monitoring programs in EU countries by describing rules and practices in a number of countries and by organising a workshop. Special supplementary issue of the web based journal Environmental Health reporting from the workshop on ethical issues and communication within bio-monitoring in Copenhagen March 2007 will be issued and a number of reports are available on the ESBIO web site and in open literature.
The recommendations are:
A protocol must be developed at an early stage describing rationale, justification of study, calculation of minimum number of study persons needed for sufficient power of study, recruitment of study persons, informed consent and information of ethics committees and before initiation of studies
Bio-banking issues needs to be solved prior to study initiation to ensure legal uses of data and samples
Incentives for participation must be considered to avoid economic pressure for participants and special concerns have to be made regarding children
Information to study persons about study results must be described and ensure respect of the right not to know
Harmonised approaches to steps of recruitment, information, consent, data protection, bio-banking, dissemination and data/sample transfer between countries and institutions should be considered e.g. in future directives/guidelines for human environmental bio-monitoring in Europe (and worldwide).

The first part contains data on the existing human biomonitoring (HBM) systems and reference values as well as information on the interlaboratory quality assurance systems and reference materials for internal daily quality control programs.
The second part includes background information on the biomarkers of exposure to substances considered priority for HBM system in Europe (cadmium, lead, mercury, cotinine), other biomarkers used on routine basis to evaluate magnitude of exposure against the reference values or to compare the levels and trends of exposure in different regions or countries (PAHs, phthalates, volatile organic compounds, pesticides, arsenic, PCDD/PCDF, PCB¿s), and biomarkers used at present for research purposes.
According to the recently published data, in spite of the downward trend in emission to the environment, the substances considered the priority (cadmium, lead, methylmercury and nicotine) can still be regarded as the possible cause of early health effects in fetuses and children. Therefore, the implementation of biomonitoring of exposure to these substances seems to be fully justified.
For all the substances discussed in the present report, validated analytical methods, external quality assurance systems and reference materials are available.

Conducting a human bio-monitoring study is a challenging task. Guidelines for all critical steps might be helpful for the successful implementation of a human bio-monitoring approach.
Beside clarification on the study design emphasis must be laid on a harmonised way of collecting, of analysing the samples and on data management. A guideline for laboratory selection (invitation to tender and evaluation of proposals) for human bio-monitoring studies has been evaluated. The guideline might be helpful for institutions or organisations conducting human bio-monitoring studies.

In order to perform a socio economic optimisation for a future EU HBM pilot project first of all tasks necessary for a HBM pilot project have been identified. Subsequently an EXCEL tool has been developed in which different parameters are variable to be filled in by the user and which calculates with the inserted figures the total necessary budget for several different study approaches.
In order to achieve the optimal approach several contradictions had to overcome, this means to maximise the number of participating Member States, the biomarkers to be measured, the number of samples, the synergies effects and to maximise the scientific progress while keeping costs as low as possible.
In addition a coordination concept has been elaborated proposing different work levels, i.e. performance of the pilot study should be done in each country by a national team; the harmonisation, support and evaluation of the study and its results should be done on EU level by multinational teams. In order to take into account the different levels of existing experiences a research-component should be established. The results have been discussed with all Member States and can be used for a future HBM pilot project.

The result is an online inventory of European human research and non-research bio-monitoring actions, either ongoing or having been carried out in the last ten years. The online structure and the procedure for self-registration of activities provide the optimum strategy for maintaining the available information both accurate and up-to-date. Additional functionalities such as user-defined searches of the activities and the message-board are also favoured by the web environment, and move the inventory closer to the concept developed for a platform for exchange of expertise and experience between human bio-monitoring (HBM) stakeholders.
The inventory holds potential for impacting all research, industry or policy sectors in any way related to HBM, in that it provides information on what is being done in the field, who is carrying out the actions, what methodologies are being applied and which laboratories have analytical experience in the area. Developments planned for the platform, such as discussion forums and web-pages dedicated to specific issues within HBM, including the organization of events, will expand this potential further through greater user involvement and a larger target public, ensuring the platform self-fulfils its potential, as a larger amount of information is registered and its usefulness consequently increases.

In order to accompany a European human bio-monitoring pilot project a communication strategy has to follow four main principles:
- There should be no double work between the involved actors
- There should be a close coordination with other EU activities in the field of E&H
- The red thread and the core statements have to match in all communication activities
- The campaign should be flexible and adaptable according to different needs
In order to meet these principles BiPRO has developed a modular concept which provides a tool to establish an effective and efficient communication. Starting point are the five modules target groups, aims, content to be communicated, actors to realise and tools to be used, which are elaborated in terms of their use for a HBM project supporting communication.
To establish a communication strategy the individual modules are linked appropriately in a way to follow the causal chain "to whom - why - what - how - who?". The concept provides a common ground for communication activities within one project even if they differ greatly from each other e.g. due to different needs and expectations. The concept is ready to be used in a future HBM pilot project by the responsible communication unit.

Conducting a human biomonitoring study it is essential to gather additional information on potential exposure pathways, behaviour and socio-demography. In the framework of ESBIO a suitable questionnaire was developed and reached a ready to use status. The questionnaire was divided into four sections.
1. The In-/Exclusion Section is aiming at the (pre-selected) mothers and addresses eligibility criteria and willingness to participate.
2. The Socio-Demography Section shall be filled by participants only and addresses socio-economic determinants of exposure.
3. The Environment and Food Frequency Section shall be filled by the participating mothers and is supposed to facilitate the individual and overall exposure assessments by elucidating the parents and children¿s participants' association with known (or suspected) exposure sources of various domains (indoor/ambient, food, lifestyle habits).
4. The Admission and Sampling Section addresses very basic health-related matters and the guided documentation of specimen collection. This section shall be managed by health officials only.
The questionnaire is available to the public via the ESBIO internet page. It might be used by other scientific groups or a guideline and serve as a standard, respectively.

In the framework of this proposal the current knowledge regarding biomarkers of exposure proposed for an EU Human Bio-monitoring Project are presented. They are arranged in two groups, representing two scenarios of basic/obligate and extended/facultative biomarkers. Beside health related aspects of the individual pollutant, a brief rationale for the selected type of specimen and proposed biomarkers is provided.
The pollutants are: lead, cadmium, mercury, cotinine, perfluorinated chemicals, polybrominated flame retardants and metabolites of phthalates, polycyclic aromatic hydrocarbons, organophosphate insecticides and pyrethroids.

A number of key aspects and recent policy developments were brought together which the future European Network on Human Biomonitoring needs to take into account:
- HBM and REACH: it was briefly outlined how HBM data may assist in the REACH assessment scheme, and also how HBM will benefit from REACH, mainly due to the generation of more and better toxicity data;
- HBM and health examination surveys: In many countries, large-scale HBM survey projects are linked to health examination surveys. Also for the European Pilot Project on Human Biomonitoring such a liaison would be possible in terms of the FEHES project, which studies the feasibility of a pan-European Health Examination Survey;
- HBM and INSPIRE: Geographical information systems may offer an excellent opportunity to combine environment, HBM and health data under one currency, being the spatial location of the data. In order to optimally integrate HBM data with other sources of information, a geographically representative sampling scheme for the European Pilot Project on Human Biomonitoring is advisable, although it remains until now uncertain what this sampling scheme could look like.

This result provides an overview of:
- The available data on pollutant concentrations in air, water, food (quality and quantity) and other relevant environmental compartment as sources of exposure;
- The past and current projects dealing with health data for the 4 key health issues within the European Environment and Health Action Plan
- Possible ways to link human biomonitoring data with both environmental and health data through either physiologically based pharmacokinetic (PBPK) modelling or spatial epidemiological statistics methods (e.g. Geographic information systems (GIS) and Bayesian Statistics)
The document identified available data, but also highlighted where no immediate information was available. In the overall assessment, 5 criteria (availability, harmonisation, geographical context, quality control and policy developments) were taken into account to identify data availability and quality on different sources of information on environmental exposure and health responses.